The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.
Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment
Benefits in attending:
Know the scope of the FDA and EU validation guidelines
Establish a 3 stage, science-and-risk-based, lifecycle process validation programme
Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
Understand how Quality by Design supports process validation
Link product requirements, to equipment verification to commercial scale process validation
Gain knowledge in qualification including Good Engineering Practice (GEP)
Apply tools such as Quality Risk Management, Design of Experiments and Statistics
Unscramble the real meaning of buzz words' such as qualification, verification, commissioning, calidation etc.
Realise significant business benefits from taking a science and risk-based approach
This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:
Development
Manufacturing
Engineering
Quality
Personnel from the pharmaceutical and biopharmaceutical industry with the following background:
Process engineers
Pharmacists
Scientists
Quality assurance professionals
Quality control managers
Late stage product and process development engineers, scientists, pharmacists
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